| Title |
Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements
|
|---|---|
| Published in |
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, July 2015
|
| DOI | 10.2147/dmso.s84005 |
| Pubmed ID | |
| Authors |
Fred Yang, Murray Stewart, June Ye, David DeMets |
| Abstract |
For type 2 diabetes mellitus treatment and clinical development, proper evaluation of cardiovascular risk has been required by regulatory agencies (eg, the US Food and Drug Administration) since cardiovascular safety is very important in this patient population. The US Food and Drug Administration issued general guidelines for cardiovascular safety evaluation that outlined the requirements considered adequate for cardiovascular safety evaluation. However, there are multiple options to obtain the data and fulfill these requirements. In this paper, we outline the potential pathways and challenges in various aspects of cardiovascular safety evaluation in type 2 diabetes clinical development, including study design, populations, and endpoints. Specifically, we discuss some challenges in statistical analysis which have implications for the design, implementation, and interpretation of these outcome studies. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 27 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 27 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 30% |
| Researcher | 5 | 19% |
| Other | 2 | 7% |
| Student > Doctoral Student | 2 | 7% |
| Student > Ph. D. Student | 1 | 4% |
| Other | 3 | 11% |
| Unknown | 6 | 22% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 15 | 56% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 7% |
| Social Sciences | 2 | 7% |
| Immunology and Microbiology | 1 | 4% |
| Economics, Econometrics and Finance | 1 | 4% |
| Other | 0 | 0% |
| Unknown | 6 | 22% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 10 October 2016.
All research outputs
#22,830,981
of 25,457,858 outputs
Outputs from Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
#1,003
of 1,184 outputs
Outputs of similar age
#236,678
of 277,768 outputs
Outputs of similar age from Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
#15
of 15 outputs
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